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FDA Panel Recommends Approval of Parkinsonís Psychosis Drug

Today an advisory committee to the U.S. Food and Drug Administration (FDA) voted 12-2 in favor of approval of Nuplazid, a drug for Parkinsonís disease psychosis. The FDA will make its decision by May 1, 2016.

PD psychosis can include hallucinations (seeing things that arenít there) and delusions (false and generally paranoid beliefs). The causes are a complex interplay of disease (often emerging later in the course of PD) and medication effect. The use of dopamine medication to treat motor symptoms has been associated with PD psychosis, as have older age, sleep disturbance, cognitive impairment, dementia and depression.

Right now doctors may adjust dopamine medications or prescribe anti-schizophrenic drugs to treat PD psychosis, but those drugs block dopamine receptors so worsen motor symptoms.

ďWeíre in kind of a quandary here with our current therapies,Ē MJFF Vice President of Medical Communications Rachel Dolhun, MD, told STAT.

Study Presents New Drug and New Assessment MethodNuplazid (the compound pimavanserin) from Acadia Pharmaceuticals works on the serotonin system, easing psychosis symptoms without worsening motor aspects of Parkinsonís disease.

ďMany existing therapies canít be applied to people with other conditions such as Parkinsonís disease,Ē said MJFF CEO Todd Sherer, PhD. ďThe pharmaceutical companies and regulators such as the FDA are taking notice of these gaps in treatment. Targeted therapies such as Nuplazid can have significant impact on quality of life.Ē

He also pointed out this study added to the field in another way. Researchers modified the traditional scale for assessment of positive symptoms hallucinations and delusions domains (SAPS H+D) to make it more applicable to PD psychosis and to remove some items more specific to schizophrenia. The SAPS-PD assessment could be used in other studies.

FDA Discusses Patient Impact and SafetyToday the FDA held an advisory committee meeting in Silver Spring, Maryland on Nuplazid, hearing from researchers and the public on the study results and the potential impact of this therapy for patients. Jamie Eberling, PhD, MJFF Director of Research Programs, who leads our symptomatic portfolio, spoke to the committee on the unmet need. The Foundation did not fund any studies of Nuplazid, though we have funded Acadia for unrelated research.

Discussion centered around meaningfulness of the results and safety. As reporter Bob Tedeschi wrote for STAT, ď8.1 percent of the patients who took the Acadia drug experienced severe side effects, compared to 4.8 percent of those who received placebo. These symptoms included irregular heart rhythms, muscle injury, and weight loss.Ē

The FDA panel did, though, vote in majority for the agency to approve the drug, saying its benefits did outweigh the risks. They also asked for further study of adverse events associated with the drug.